InfuTronix LLC recalls Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT…

Recall date

October 19, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0832-2022

FDA classification

Class II

Brand / firm

InfuTronix LLC

Sold / distributed

US Nationwide distribution in the states of NC and OH.

Why it was recalled

An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP